Testosterone
Sold as Testogel, Testafeme, Testaforte, Tensitev, Testosterone cipla, Androgel
(8R,9S,10R,13S,14S,17S)-17-Hydroxy-10,13-dimethyl-1,2,6,7,8,9,11,12,14,15,16,17-dodecahydrocyclopenta[a]phenanthren-3-one
Drag to rotate. Structure from PubChem CID 6013.
Background
Registration
- Applicants
- 4
- Registrations
- 6
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Medi Challenge (Pty) Ltd | Testogel, Androgel | 50 mg/5 g | 400726, A400260 | S5 | PIPIL |
| Pharmacorp (Pty) Ltd | Testafeme, Testaforte | 10 mg, 50 mg in 1 ml or 100 mg in 2 ml | 550726, 550727 | S5 | PIPIL |
| Teva Pharmaceuticals (Pty) LtdCertificate held by Teva Pharmaceuticals (Pty) Ltd. | Tensitev | 40/5; 40/10; 80/5; 80/10mg | 570340 | S5 | PIPIL |
| Cipla Medpro (Pty) Ltd | Testosterone cipla | 1000 mg | 570491 | S5 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Testogel | 50 mg/5 gTransdermal gel. | 400726A40/21.7/0726Approved 27 October 2022 | Registered | S5 | PIPIL |
| Testafeme EACH 1,0 ml CREAM CONTAINS TESTOSTERONE 10,0 mg | 10 mgCream. | 55072655/21.7/0726Approved 31 October 2023 | Registered | S5 | PIPIL |
| Testaforte EACH 1,0 ml CREAM CONTAINS TESTOSTERONE 50,0 mg | 50 mg in 1 ml or 100 mg in 2 mlCream. | 55072755/21.7/0727Approved 30 May 2023 | Registered | S5 | PIPIL |
| Tensitev 40/5 Each Tablet contains: Telmisartan 40,0 mg, Amlodipine Besilate equivalent to Amlodipine | 40/5; 40/10; 80/5; 80/10mgTablets. | 57034057/7.1.13/0340Approved 24 June 2025 | Registered | S5 | PIPIL |
| Testosterone cipla EACH 4,0 ml SOLUTION CONTAINS: TESTOSTERONE UNDECANOATE 1 000,0 mg | 1000 mgSolution for injection | 57049157/21.7/0491Approved 9 September 2025 | Registered | S5 | PIPIL |
| Androgel EACH 5,0 g SACHET CONTAINS TESTOSTERONE 50,0 mg | 50 mg/5 gTransdermal gel. | A400260A40/21.7/0260Approved 27 October 2022 | Registered | S5 | PIPIL |
Regulatory status
Where S5 sits on the scale
Prescription-only, with tighter controls on repeats.
Schedule 5 medicines need a prescription, and repeat dispensing is capped at six months in total; the prescriber must state upfront how many times, and at what intervals, it may be repeated. Extra limits apply to some uses: if it is being used for its anxiolytic, antidepressant, tranquillising or analgesic properties, it cannot be prescribed for longer than six months without a further consultation. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.
Schedule S5, read from the product's PI-PIL leaflet.
Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it.
Consolidated Schedules listings for Testosterone
S5: Testosterone
- except subcutaneous implants thereof when specifically intended and registered as a veterinary production improver in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Consolidated Schedules 06 July 2026, lines 9709 to 9711
Pharmacological class: Male sex hormones. (class 21.7)
This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.
SAHPRA documents
Schedule Verification
Testogel, Medi Challenge (Pty) Ltd is scheduled S5 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.